Letzte Aktualisierung: 06.05.2026

Hirntumor [C71]

PerSurge

Aktive Studien

Studieninformationen

Clinical and translational placebo-controlled study of Perampanel treatment around Surgery in patients with progressive glioblastoma (PerSurge Trial)

Behandlungszentren im CIO

Bonn


Ziele

Primäres Prüfziel

The primary aim of the trial is to demonstrate the efficacy of pre-surgical perampanel compared to placebo treatment with respect to A) the shift of mRNA expression patterns to a lower connectivity score in tumour tissue, and B) the presurgical tumour growth rate as assessed by tumour volume [cm³] per a central blinded independent review committee (BIRC) based on AI-quantified MRI parameters (T2/FLAIR-weighted images) in patients with recurrent/progressive glioblastoma willing to adhere to the randomised treatment and who will undergo surgery.

Sekundäre Prüfziele für die Behandlungsarme:

Efficacy: To explore the efficacy of perampanel compared to placebo as regards  kinetics in contrast-enhancing (T1CE images) tumour volume by central AI-based MRI assessment per BIRC [pre-surgical; postsurgical ]  kinetics in tumour volume (T2/FLAIR) by central AI-based MRI assessment per the BIRC [post-surgical]  health-related quality of life (HRQoL) and symptoms as assessed by the EORTC QLQ-C30 and QLQ-BN20 patient questionnaires,  severity of cognitive impairment as assessed by the mini-mental state examination (MMSE)  overall survival (OS)  progression-free survival (PFS) (from randomisation until progression according to RANO criteria)  epileptic seizure activity Safety:  To check for the occurrence of the adverse effects reported in the summary of the medical product characteristics (SmPC) of the drug and to compare between both treatments


Design

Design

Phase

IIa

Zentren

Multizentrisch

Datenerhebung

Prospektiv

Interventionsgruppen

Zweiarmig

Verblindung

Doppelblind

Erkrankung

Diagnose

Hirntumor [C71]

Diagnosenbeschreibung

histologically proven recurrent or progressive glioblastoma that are candidate for surgery with a safe waiting time of up to 5 weeks

Mutation

Patienten

Alter

18+ Jahre

Einschlusskriterien

1. Histologically confirmed glioblastoma, progressive or recurrent after 1 or 2 lines of prior treatment, involving one radiotherapy and drug treatments (temozolomide, lomustine and/or other) according to institutional standards or prior trial participation, >3 months after end of radiotherapy, and therapy for relapse not yet started. 2. Indication for surgical resection of progressive or recurrent tumour tissue 3. A sufficient amount of resected tumour tissue (minimum 0.5 cm3) is expected to be available for the trial-specific molecular, morphological, functional and perampanel level analysis. 4. Tumour progression according to RANO criteria 5. Age ≥18 years 6. Karnofsky Performance status score (KPS) ≥ 60% 7. Life expectancy > 3 months 8. Willing and able to comply with regular neurocognitive and health-related quality of life tests/questionnaires. 9. Written informed consent. 10. Cognitive state to understand rationale, necessity and individual consequences of study therapy and procedures. 11. Female patients with reproductive potentiala must use an approved contraceptive method during and for 4 weeks after the end of trial medication (Pearl Index <1%) 12. Female patients with reproductive potential: a negative serum pregnancy test (beta-HCG) must be obtained prior to treatment start.

Ausschlusskriterien

1. Participation in other ongoing interventional clinical trials. 2. Inability to undergo contrast-enhanced MRI. 3. Inability to undergo surgery (e.g. because of need for continuous anticoagulation, known bleeding disorders, thrombocytopenia <50/nl, pre-existing wound healing problems). 4. According to the assessment of the local investigator, a safe waiting interval of 4-5 weeks for surgical resection is not possible because the growth dynamics, configuration, or location of the brain tumour, or any complication, require immediate or earlier surgical intervention to save the patient from harm (e.g. by herniation or other emergency situations, or brain damage due to tumour mass effects) 5. Any continued or planned standard or experimental treatment for the tumour other than resection, including antiangiogenic therapy (such as Bevacizumab), and local therapy in addition to the planned resection, including BCNU wafers, loco-regional hyperthermia, tumour bed irradiation, and photodynamic therapy. 6. Tumour carries a known mutation in the IDH1 or IDH2 gene 7. Severe or significant abnormal (≥ Grade 3 CTCAE v5.0) laboratory values for haematology (Hb, WBC, neutrophils, or platelets), liver (serum bilirubin, ALT, or AST) or renal function (serum creatinine). 8. Known active tuberculosis; HIV infection or active Hepatitis B (HBV) or Hepatitis C (HCV infection, or active infections requiring oral or intravenous antibiotics or that can cause a severe disease and pose a severe danger to lab personnel working on patients' blood or tissue (e.g. rabies). 9. Any prior treatment with perampanel 10. Pre-existing conditions like psychosis, aggression or suicidal thoughts that are considered as not allowing Perampanel treatment according to the assessment of the local investigator. 11. Concomitant intake of enzyme-inducing antiepileptic drugs (EIAEDs: carbamazepine, eslicarbazepine, oxcarbazepine, phenobarbital, phenytoin, primidon, rufinamid) 12. Steroid intake of more than 4 mg dexamethasone (or equivalence dose) in the last week, or expected indication for it in the foreseeable future 13. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 2 years unless the patient has been disease-free for 2 years. 14. Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or the absorption of oral medications or that would, in the opinion of the Principal Investigator, pose an unacceptable risk to the patient in this study. 15. Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol requirements and/or follow-up procedures; those conditions should be discussed with the patient before trial entry. 16. Pregnancy or breastfeeding. 17. History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. 18. The presence of any other concomitant severe, progressive, or uncontrolled renal, hepatic, haematological, endocrine, pulmonary, cardiac, or psychiatric disease, or signs or symptoms thereof, that may affect the subject's participation in the study, according to investigators judgement.

Therapie

Intervention

Substanz

Zuständige Gesamtstudie

Sponsor

Leiter der klinischen Prüfung (LKP)

Studiengruppen/-zentrale

Kontakt Klinische Studien

CIO Aachen: Uniklinik RWTH Aachen, +49 (0) 241 80-85490

CIO Bonn: Uniklinik Bonn, +49 (0) 228 287-16036

CIO Köln: Uniklinik Köln, +49 (0) 221 478-0

CIO Düsseldorf: Uniklinik Düsseldorf, +49 (0) 211 81-04150 (Mo-Do)